220 JOURNAL OF COSMETIC SCIENCE • The subjects' privacy must be assured. The impact of the study on the subjects' physical and mental integrity and on their personality must be minimized. • Hazards must be predictable. • The accuracy of the results of such research must be preserved in publications. • Subjects must be informed about the study and of their right to abstain or withdraw: they must give consent (preferably in writing). • Informed consent must be obtained by a physician independent of the subject. • Informed consent should be obtained from a legal guardian in the case of legal incompetence. Informed consent from the responsible relative is necessary for minors, where physical or mental incapacity make it otherwise impossible for the subject to give informed consent. Minors should also give their own consent where this is possible. Additional principles are listed for medical research combined with professional care, · and the following principles are emphasized for non-therapeutic (non-clinical) biomedi­ cal research on human subjects: • The physician remains the subject's protector. • Subjects should be volunteers who are healthy persons or patients for whom the research is not related to their illness. • The investigator team should cease the work if the study would harm the subject. • The interest of science and society should never take precedence over a subject's well-being. The concept of scientific peer review of research proposals was strengthened by the 197 5 amendment to the Helsinki declaration. In the UK a system of local research ethics committees and multi-center research ethics committees have existed for NHS research since 1966 and 1997, respectively. A re­ quirement for peer review appeared in the 1967 Royal College of Physicians guidelines (15 ). They later issued Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (16). These are somewhat biased towards the researcher, with an instruction to ethics committees to be ever aware of the need to avoid impeding good medical research. The College also published a report, Research on Healthy Human Vol­ unteers (1 7). Recently, the UK implemented the EC "clinical trials" Directive 2001/20/EC with promulgation of The Medicines for Human Use (Clinical Trials) Regulations 2004. Under these regulations no person shall be permitted to conduct a clinical trial unless there has first been a favorable opinion obtained from an ethics committee. The UK Ethics Committees Authority is responsible for establishing, recognizing and monitoring UK ethics committees, though this relates to those committees reviewing trials on medicinal products only. Good clinical research practices have been produced throughout the developed world, and a major milestone was publication of the guidelines from the International Con­ ference on Harmonization of GCP, which attempt to standardize requirements for Europe, Japan, and the USA. These address ethical considerations for licensed trials (18). CONCLUSION Philosophical theories abound ranging from consequentialism ( the morals of an action should be judged on the basis of the consequences that follow) to deontological theories

ETHICS OF HUMAN TESTING: BACKGROUND 221 (which judge the morality of an action on the original intentions, motivations, and obligations it seeks to fulfill, i.e., the end does not justify the means). During the past 2000 years fundamental principles have emerged on the ethical standards for medical research on human subjects. The implications of these general ethical rules for non­ medical bio-research are discussed in Part II. REFERENCES (1) J. Katz (Ed.), Experimentation with Human Beings (Russel Sage Foundation, New York, 1972). (2) R. Platt, The ethical basis of medical science, Sci. Basis Med. Ann. Rev., 1-15 (1966). (3a) C. D. Leake (Ed.), Percival's Medical Ethics (Williams and Williams, Baltimore, 1927). (36) G. J. Annas and M.A. Grodin (Eds.), The Nazi Doctors and the Nuremberg Code (Oxford University Press, 1992). (4) H. Beecher, Research and the Individual Subject (Little Brown and Co, Boston, 1970). (5) C. Bernard, An Introduction to the Study of Experimental Medicine translated by H. C. Green (Macmillan, New York, 1927). (6) J. Vollmann and R. Winau, The Prussian regulation of 1900: Early ethical standards for human experimentation in Germany, !RB a Review of Human Subjects Research, 18(4), 9 (1996). (7) Anon, Int. Digest Health Leg., 31, 408-411 (1980). (8) J. Warren, et al., The effect of venescetion and the pooling of blood in the extremeties on atrial pressure and cardiac output in normal subjects with observations on acute circulatory collapse in three in­ stances, Clin. Invest., 24(3), 337-344 (1945). (9) K. Mellanby, Human Guinea Pigs (Blackfriars Press, Leicester, 1945). (10) H.K. Beecher, Ethics and clinical research, N. Eng.]. Med., 274, 1354-1360 (1966). (11) Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel (US Government Printing Office, Washington, DC, 1973). (12) NHS Executive West Midlands Regional Office, Report of a Review of the Research Framework in North Staffordrhire Hospital NHS Trust (Griffiths Report) (Leeds, NHS Executive, 2000). (13) The Royal Liverpool Children's Inquiry, January 2001 (The Stationary Office, 2001). (14) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Department of Health, Education anl Welfare, Washington, DC, 1979). (15) C. Bassiouni, T. G. Baffes, and J. T. Evrard, An appraisal of human experimentation in international law and practice: The need for international regulation of human experimentation. J Crim. Law Criminal., 72(4), 1597-1666 (1981). (16) Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (Royal College of Physicians, London, 1990). (1 7) Royal College of Physicians, Research on Healthy Human Volunteers (Royal College of Physicians, London, 1986). (18) /CH Guideline for Good Clinical Practice (International Federation of Pharmaceutical Manufacturers Associations, Paris, 1996).